Real-Time Cholangioscopy Artificial Intelligence Evaluation of Biliary Strictures

Conditions

• Biliary Stricture

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Study Details

The purpose of this study is to demonstrate the feasibility and validity of a previously developed peroral cholangioscopy (POC) convolutional neural network (CNN) to determine the etiology of biliary strictures when used in real-time.

Key Dates

First listed

Mar 22, 2023

Start date

Apr 1, 2023

Status verified

Apr 2026

Primary completion

Mar 31, 2027

Completion

Sep 30, 2027

Study Design

Enrollment

100 participants (estimated)

Arms

• Arm: Patients undergoing cholangioscopy for evaluation biliary stricture

Primary Outcome Measure

POC-CNN Model AUC [ Time Frame: Patients will be considered negative for malignancy only with 12 months of negative follow-up or definitive negative surgical histology. ]

Central Contacts

• Liz Lemke
  507-284-2511
  [email protected]

Locations (2)

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